New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

11/26/2002

Trade Name:

Strattera

Generic Name or Proper Name (*):

atomoxetine

Indications Studied:

Attention-Deficit Hyperactivity Disorder

Label Changes Summary:

* Safety and effectiveness established down to 6 years of age * It is unknown whether final adult height or weight is affected by treatment. Patients on long-term treatment should be monitored * The effectiveness of atomoxetine beyond 9 weeks and safety beyond 1 year in pediatric patients, has not been systematically evaluated in controlled trials